Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

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Maia
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Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby Maia » Mon Feb 13, 2017 2:39 pm

New trial at NIH (Bethesda, Maryland)
* #NCT03050814
*UPDATE March 20th: RECRUITING
*Only for MSS CRC
*Only for UNTREATED MSS CRC (recently diagnosed)
*Randomized (but "Arm A participants can join Arm B").
*FIRST, it will be "A LEAD IN COHORT, comprising THE FIRST 6 EVALUABLE SUBJECTS ENROLLED".
* Arm A: Ad-CEA vaccine + Avelumab (anti PD-L1) + standard of care VS. Arm B: standard of care
*"Standard of care" means: FOLFOX + Avastin; later, Xeloda + Avastin
*NCI-17-C-0057 (NCI Protocol ID)
Investigator: Austin G. Duffy, M.D. Referral contact: Diana Martin, R.N. diana.martin@nih.gov.. 301.451.2163 301-496-9574

https://clinicaltrials.gov/ct2/show/study/NCT03050814

And that should show to any oncologist how immunotherapy trials are NOT the last resource.
Last edited by Maia on Mon Mar 20, 2017 9:26 pm, edited 1 time in total.

mariane
Posts: 482
Joined: Sun Sep 13, 2015 6:16 pm

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby mariane » Mon Feb 13, 2017 11:18 pm

This one is very interesting.

I cannot believe how fast the immunotherapy is progressing. It is changing cancer world...

I also like the
A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors for CEA expressing tumors.
mom of almost 8 years old twins, dx @ 40 with stage 4 upper rectal cancer with liver mets on 6/26/2015, CEA 140
8/2015 - beginning chemo: 4xFOLFIRINOX, 2xFOLFOX, 8xFOLFIRI, 10x5FU, 12xFUDR
4 surgeries complete pathological response
CEA<2 since 10/2015
NED since May 2016

Praise God for every day with my family!

Steph20021
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Location: Ontario, Canada

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby Steph20021 » Tue Feb 14, 2017 2:41 pm

Please delete-duplicate
Last edited by Steph20021 on Tue Feb 14, 2017 2:43 pm, edited 1 time in total.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS
2/1/14-subtotal col, R ovary removed & temp ileo
3/14-9/14- 12 rds folfox
10/14- rev ileo
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
7/15- flex sig- all clear
8/15-HIPEC, hysterectomy et al, 2nd temp ileo, NED?
09/15- cea 0.9
Current: abdo wall mets and lymph nodes
Feb/17- 1 wk radiation to abdo wall
Currently on folfiri 4 life

Steph20021
Posts: 422
Joined: Sat Dec 27, 2014 4:58 pm
Location: Ontario, Canada

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby Steph20021 » Tue Feb 14, 2017 2:43 pm

mariane wrote:This one is very interesting.

I cannot believe how fast the immunotherapy is progressing. It is changing cancer world...

I also like the
A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors for CEA expressing tumors.


What is the NCT # of this trial with RO695688?? I read in Julie's recent blog that she will be starting it.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS
2/1/14-subtotal col, R ovary removed & temp ileo
3/14-9/14- 12 rds folfox
10/14- rev ileo
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
7/15- flex sig- all clear
8/15-HIPEC, hysterectomy et al, 2nd temp ileo, NED?
09/15- cea 0.9
Current: abdo wall mets and lymph nodes
Feb/17- 1 wk radiation to abdo wall
Currently on folfiri 4 life

mariane
Posts: 482
Joined: Sun Sep 13, 2015 6:16 pm

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby mariane » Tue Feb 14, 2017 3:27 pm

It is Julie's trial. I checked.

Tom in UK was on it and responded well. He stopped responding but it gave him time and shrinkage of most mets.
I liked the description of that since Maia posted it here in November or December. In December Tim posted very encouraging news. It stopped working for him but the duration of response may vary.
Immunotherapy shows various grade of response on tumors most likely from the heterogenity of mutations status. Each tumor may vary genetically. Tumor are also genetically unstable with their constantly dividing cells. New mutations are being created all the time. It is how I see it.

Maia surely knows more.
mom of almost 8 years old twins, dx @ 40 with stage 4 upper rectal cancer with liver mets on 6/26/2015, CEA 140
8/2015 - beginning chemo: 4xFOLFIRINOX, 2xFOLFOX, 8xFOLFIRI, 10x5FU, 12xFUDR
4 surgeries complete pathological response
CEA<2 since 10/2015
NED since May 2016

Praise God for every day with my family!

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Maia
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Joined: Fri Aug 24, 2012 8:00 am

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby Maia » Tue Feb 14, 2017 4:20 pm

Steph20021 wrote:What is the NCT # of this trial with RO695688?? I read in Julie's recent blog that she will be starting it.


It's #NCT02650713
A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors

https://clinicaltrials.gov/ct2/show/NCT02650713
Yes, our Julie is starting it. Everything crossed for her!
(you can get more information if you put the trial number in the clinical trial finder in my signature)
BTW, there is a trial ongoing with the RO688 (the nickname of the drug) as monotherapy: https://clinicaltrials.gov/ct2/show/NCT02324257

Tim had progression, apparently. But it worked during a while, even on his BRAF mutated CRC.
Robert, other patient on that trial, at MSK, continues doing well --reported a couple of weeks ago.

mariane
Posts: 482
Joined: Sun Sep 13, 2015 6:16 pm

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby mariane » Tue Feb 14, 2017 8:54 pm

I am curious how mutation status influences immunotherapy. How BRAF influances response? Melanoma has BRAF and responds well. We know -the more mutations, the better- that's why MSI respond.
We know how some mutations influence chemo response.
Do you know how common known mutation status influences immunotherapy?? Some "bad" mutations may not be bad as a target for immunotherapy (?????)
???????
Last edited by mariane on Tue Feb 14, 2017 9:03 pm, edited 1 time in total.
mom of almost 8 years old twins, dx @ 40 with stage 4 upper rectal cancer with liver mets on 6/26/2015, CEA 140
8/2015 - beginning chemo: 4xFOLFIRINOX, 2xFOLFOX, 8xFOLFIRI, 10x5FU, 12xFUDR
4 surgeries complete pathological response
CEA<2 since 10/2015
NED since May 2016

Praise God for every day with my family!

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Maia
Posts: 2216
Joined: Fri Aug 24, 2012 8:00 am

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby Maia » Tue Feb 14, 2017 9:01 pm

So far, not data about the more common mutations (RAS (KRAS and NRAS), BRAF, p53, PIK3, APN) being pertinent for (good or bad) response to immunotherapy.

mariane
Posts: 482
Joined: Sun Sep 13, 2015 6:16 pm

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby mariane » Tue Feb 14, 2017 9:06 pm

Thank you Maia! :):)
mom of almost 8 years old twins, dx @ 40 with stage 4 upper rectal cancer with liver mets on 6/26/2015, CEA 140
8/2015 - beginning chemo: 4xFOLFIRINOX, 2xFOLFOX, 8xFOLFIRI, 10x5FU, 12xFUDR
4 surgeries complete pathological response
CEA<2 since 10/2015
NED since May 2016

Praise God for every day with my family!

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Maia
Posts: 2216
Joined: Fri Aug 24, 2012 8:00 am

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby Maia » Tue Feb 14, 2017 9:12 pm

mariane wrote:Melanoma has BRAF and responds well. We know the more mutations

No regarding immunotherapy, but wanted to point out that he BRAF mutations act different in melanoma than in CRC, that's for sure: MEK inhibitors work well against BRAF in melanoma, not well for BRAF CRC. Only recently there is a triplet that show some activity.
The common mutations i mentioned above are part of a "different system" of mutations than those called "microsallite status". Only those of this system (MSS vs MSI) seem pertinent for prediction of response to immunotherapy (at the moment... who knows in some months : )

mariane
Posts: 482
Joined: Sun Sep 13, 2015 6:16 pm

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby mariane » Tue Feb 14, 2017 11:23 pm

MSI - have constantly mutating genome/unstable genome - so their mutations are easy target since they have thousands of mutations.

I need to read more from newer publications if find something for free. What I know is old....

Why is melanoma highly immunogenic? I have never dedicated time to research it...

I know that BRAF in crc responds only to triplet therapy at this point.As I suspected we do not know much how mutation status influences responses to immuno. There will be statistics soon whenever we will see more positive trials.
We still know little.

It is fantastic, exciting time for scientists. Great for the patients as well.
mom of almost 8 years old twins, dx @ 40 with stage 4 upper rectal cancer with liver mets on 6/26/2015, CEA 140
8/2015 - beginning chemo: 4xFOLFIRINOX, 2xFOLFOX, 8xFOLFIRI, 10x5FU, 12xFUDR
4 surgeries complete pathological response
CEA<2 since 10/2015
NED since May 2016

Praise God for every day with my family!

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Maia
Posts: 2216
Joined: Fri Aug 24, 2012 8:00 am

Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby Maia » Mon Mar 20, 2017 9:29 pm

Updated the starter post since the trial is now

RECRUITING.

If you are recently diagnosed, Stage IV, I'd recommend to read and read so you understand what the treatments are proposing you, so that way you're in an optimal position to judge if this IMMUNOTHERAPY trial might be adequate for you.

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juliej
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Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby juliej » Tue Mar 21, 2017 3:31 pm

I love more trials showing up for MSS CRC! :D :D :D

This one is very unusual - Avelumab, a PD-L1 antibody plus an adenoviral vector vaccine against CEA. I'm assuming the vaccine uses the Ad5 [E1-, E2b-] gene delivery platform, which induces more potent immune responses in Ad-immune hosts. This vaccine has shown good results in some very early Phase I trials. And since you get standard of care in addition to the immunotherapy portion, it seems like a good possibility for those newly diagnosed.

Thanks, Maia, for putting this on our radar!

Hugs from your fellow zombie-hunter!!!
Juliej
Stage IV, liver/lung mets 8/4/2010
Xelox+Avastin 8/18/10 to 10/21/11
LAR, liver resec, HAI pump 11/11
Double lung surgery + ileo reversal 2/12
Adjuvant Xeloda 3-9/12
VATS rt. lung 12/21/12 - benign granuloma!
NED 3/17/12 to 2/20/2017, CEA<1

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Maia
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Re: Immuno trial only for UNTREATED MSS CRC (recently diagnosed)

Postby Maia » Tue Mar 21, 2017 4:44 pm

juliej wrote: And since you get standard of care in addition to the immunotherapy portion, it seems like a good possibility for those newly diagnosed.


Exactly!

Huge hug to you, I'm so happy to see you kicking arses! :)


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